Epirubicin API Manufacturer & Supplier in India

Epirubicin is an anthracycline antibiotic used as an antineoplastic agent in the treatment of breast cancer, gastric cancer, and other solid tumours. Mediocon Inc manufactures Epirubicin API to IP/BP/EP/USP pharmacopoeial standards in its GMP-certified facility in Aurangabad, Maharashtra, India.

Our Epirubicin API is manufactured under strict GMP and oncology-grade quality controls, supplied to global injectable oncology pharmaceutical manufacturers with full regulatory documentation.

Key Features

• High-purity pharmaceutical grade API
• IP / BP / EP / USP compliant
• Full CoA and MSDS documentation
• GMP certified manufacturing

Applications

• Breast cancer chemotherapy
• Gastric cancer treatment
• Bladder cancer adjuvant therapy
• Oncology injectable formulation manufacturing

Why Choose Mediocon

• ISO 9001:2015 & GMP certified manufacturing
• Consistent batch-to-batch quality with full CoA
• Export-ready documentation: COO, MSDS, DMF
• Flexible MOQ for both R&D and commercial scale
• Dedicated QA support for regulatory filings

Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Epirubicin (CAS 56420-45-2) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Epirubicin is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP, BP, USP, EP). Every batch undergoes full analytical testing — identity (IR/HPLC), assay, related substances, residual solvents (ICH Q3C), heavy metals, and microbial limits — before release with a Certificate of Analysis.

Export Markets

• USA — FDA-registered facility; DMF support available for ANDA/NDA filings
• Europe — EMA-compliant documentation; CEP/EDMF support on request
• Africa & Middle East — WHO-GMP certified; competitive pricing for emerging markets
• Southeast Asia — established logistics network; temperature-controlled shipments
• India domestic — schedule H/X compliance; all state licensing documentation provided

Quality & Compliance

• ISO 9001:2015 certified quality management system
• GMP-certified manufacturing facility, Aurangabad, Maharashtra
• Full batch traceability from raw material to finished API
• Stability data available (ICH Q1A guidelines) for regulatory submissions
• Dedicated QA team for customer audits and regulatory queries